mHSPCPhase 2LoDARONCT07503379
Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC
A Phase 2 study testing Darolutamide + ADT Combined with Low-dose Docetaxel in people with mHSPC, run by Yonghong Li at 3 sites in China.
Trial summary
This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- mHSPC
- What is being tested?
- Darolutamide + ADT Combined with Low-dose Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 109 participants
- Where
- 3 sitesChina
- Study dates
- 16 Apr 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Males ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review
- Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment
- Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before included. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks before the initiation of study is recommended. First generation anti-androgen has to be stopped prior to included.
- An Eastern Cooperative Oncology Group performance status of 0 or 1
Who cannot join
- 1. Prior treatment with:
- LHRH agonist/antagonists started more than 12 weeks before before the initiation of study
- Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors
- Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
- Chemotherapy or immunotherapy for prostate cancer prior to randomization 2. Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before initiation of study 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
zhenyu yang contact
China3 sites, 3 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510062
Zhenyu Yang, +86-13902290670, yangzy@sysucc.org.cn
- Not yet recruiting
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou
Bin Wang, 13178827278, 972364766@qq.com
Bin Wang
- Not yet recruiting
Meizhou People's Hospital
Meizhou
Nanhui Chen, 13823880488, chennanhuiht@163.com
Nanhui Chen
About this study
Official title: Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study
This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients.
The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.
- Conditions
- mHSPC
- Being tested
- Darolutamide + ADT Combined with Low-dose Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide + ADT Combined with Low-dose DocetaxelDrug
- Darolutamide This study used Darolutamide from Bayer Pharmaceuticals, with a specification of 300mg per tablet. The dose is 600 mg （2 tablets）, taken twice a day with meals.
- Docetaxel The dose of docetaxel is 60mg/m2, administered intravenously on the first day of each cycle. This cycle should be repeated every 3 weeks for a maximum of 6 cycles.
Docetaxel can be administered in combination with prednisone/prednisolone at the discretion of the researcher. To prevent hypersensitivity and fluid retention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable PSA(<0.2ng/ml) at 24w
Measured: 6 months
Undetectable PSA(<0.2ng/ml) at 24w
Defined as the ratio of the number of subjects whose PSA less than 0.2ng/ml to the total number of subjects whose PSA response can be evaluated within 24 weeks
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start16 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for mHSPCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonghong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yonghong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503379
- Sponsor's protocol ID
- 2025-FXY-342
- Acronym
- LoDARO
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamiya N, Suzuki H, Ueda T, Sato N, Nakatsu H, Mikami K, Sato N, Nomura K, Akakura K, Okano T, Ooki T, Naya Y, Ota S, Masai M, Ichikawa T. Clinical outcomes by relative docetaxel dose and dose intensity as chemotherapy for Japanese patients with castration-resistant prostate cancer: a retrospective multi-institutional collaborative study. Int J Clin Oncol. 2014 Feb;19(1):157-64. doi: 10.1007/s10147-012-0510-9. Epub 2013 Jan 9.
PubMed 23299278Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
PubMed 35179323Jimenez N, Garcia de Herreros M, Reig O, Marin-Aguilera M, Aversa C, Ferrer-Mileo L, Garcia-Esteve S, Rodriguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MA, Cros S, Chirivella I, Domenech M, Figols M, Carles J, Suarez C, Herrero Rivera D, Gonzalez-Billalabeitia E, Civico C, Sala-Gonzalez N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Prognostic Gene Expression Signature Based on RB1, PTEN, and TP53 in Metastatic Hormone-sensitive Prostate Cancer Patients. Eur Urol Oncol. 2024 Aug;7(4):954-964. doi: 10.1016/j.euo.2023.12.012. Epub 2024 Mar 1.
PubMed 38429210
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT07503379
- Acronym / sponsor ID
- LoDARO / 2025-FXY-342
- Conditions
- mHSPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Yonghong LiUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients.
The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- Males ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review
- Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment
Key exclusion criteria (5 listed)
- LHRH agonist/antagonists started more than 12 weeks before before the initiation of study
- Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors
- Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
- Chemotherapy or immunotherapy for prostate cancer prior to randomization 2. Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before initiation of study 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darolutamide + ADT Combined with Low-dose Docetaxel1. Darolutamide This study used Darolutamide from Bayer Pharmaceuticals, with a specification of 300mg per tablet. The dose is 600 mg （2 tablets）, taken twice a day with meals. 2. Docetaxel The dose of docetaxel is 60mg/m2, administered intravenously on the first day of each cycle. This cycle should be repeated every 3 weeks for a maximum of 6 cycles. Docetaxel can be administered in combination with prednisone/prednisolone at the discretion of the researcher. To prevent hypersensitivity and fluid retention. | Drug | – |
Primary outcome
Undetectable PSA(<0.2ng/ml) at 24w
Time frame: 6 months
Undetectable PSA(<0.2ng/ml) at 24w
Time frame: 6 months
Defined as the ratio of the number of subjects whose PSA less than 0.2ng/ml to the total number of subjects whose PSA response can be evaluated within 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 23299278Kamiya N, Suzuki H, Ueda T, Sato N, Nakatsu H, Mikami K, Sato N, Nomura K, Akakura K, Okano T, Ooki T, Naya Y, Ota S, Masai M, Ichikawa T. Clinical outcomes by relative docetaxel dose and dose intensity as chemotherapy for Japanese patients with castration-resistant prostate cancer: a retrospective multi-institutional collaborative study. Int J Clin Oncol. 2014 Feb;19(1):157-64. doi: 10.1007/s10147-012-0510-9. Epub 2013 Jan 9.
- Results publication: PubMed 35179323Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
- Results publication: PubMed 38429210Jimenez N, Garcia de Herreros M, Reig O, Marin-Aguilera M, Aversa C, Ferrer-Mileo L, Garcia-Esteve S, Rodriguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MA, Cros S, Chirivella I, Domenech M, Figols M, Carles J, Suarez C, Herrero Rivera D, Gonzalez-Billalabeitia E, Civico C, Sala-Gonzalez N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Prognostic Gene Expression Signature Based on RB1, PTEN, and TP53 in Metastatic Hormone-sensitive Prostate Cancer Patients. Eur Urol Oncol. 2024 Aug;7(4):954-964. doi: 10.1016/j.euo.2023.12.012. Epub 2024 Mar 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
zhenyu yang contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darolutamide + ADT Combined with Low-dose Docetaxel in people with mHSPC, run by Yonghong Li at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yonghong Li (13711376697, liyongh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable PSA(<0.2ng/ml) at 24w (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503379, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.